The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (\<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (\>) 100 IU/mL to \<= 500 IU/mL at baseline.
Hepatitis B virus (HBV) virus infects the human liver. It consists of a nucleocapsid with hepatitis B core (HBc) protein and a membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic hepatitis B (CHB) virus infection may lead to liver cirrhosis and hepatocellular carcinoma (HCC). Recent guidelines (European Association for the Study of the Liver \[EASL\] guidelines, Asian Pacific Association for the Study of the Liver \[APASL\] guidelines) suggest that discontinuation of treatment with nucleos(t)ide analog (NA) (Entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) in non-cirrhotic Hepatitis B e antigen (HBeAg) negative patients after a minimum of three years of viral suppression can trigger changes in virological and immune composition resulting in achieving HBsAg seroclearance (up to 25 percent \[%\]). The study will be conducted in 3 phases: screening phase (up to 6 weeks), baseline visit (1 day), and post-NA discontinuation phase (up to 96 weeks) which refers to the phase after baseline, in which treatment will be discontinued (off treatment). Discontinuation of NA treatment is considered as study intervention in this study. Collection of core liver biopsy, fine needle aspiration (FNA), and blood samples are considered study investigations/procedures. The participants will be followed for up to 2 years post-NA treatment discontinuation. The total duration of an individual participation will be up to 102 weeks (including up to 6 weeks for screening and baseline).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
ETV will continue throughout screening and will be stopped at baseline.
TDF will continue throughout screening and will be stopped at baseline.
TAF will continue throughout screening and will be stopped at baseline.
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance After Discontinuation of Nucleos(t)ide Analog (NA) Treatment
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Time frame: At Week 24
Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Time frame: At Week 48
Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment
Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.
Time frame: At Week 96
Percentage of Participants with Flares
Percentage of participants with flares (virologic, biochemical, and clinical) measured by blood markers (such as HBsAg, hepatitis B virus deoxyribonucleic acid \[HBV DNA\], and alanine aminotransferase \[ALT\]) will be reported.
Time frame: At Week 24, Week 48, and Week 96
Change from Baseline Over Time in HBsAg Level
Change from baseline over time in HBsAg level will be reported.
Time frame: Baseline up to 96 weeks
Change from Baseline Over Time in HBV DNA level
Change from baseline over time in HBV DNA level will be reported.
Time frame: Baseline up to 96 weeks
Time to Achieve First HBsAg Seroclearance
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Time to achieve first HBsAg seroclearance will be reported.
Time frame: Up to 96 weeks
Percentage of Sustained Clinical Responders
Percentage of sustained clinical responders (those with HBsAg seroclearance) will be reported.
Time frame: At Week 24, Week 48, and Week 96
Percentage of Participants with HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion will be reported.
Time frame: At Week 24, Week 48, and Week 96
Percentage of Participants with Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that results in any of the following conditions that is death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity.
Time frame: Up to 96 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Parameters
Percentage of participants with abnormalities in clinical laboratory parameters will be reported.
Time frame: Up to 96 weeks
Percentage of Participants Who Meet the NA Re-Treatment Criteria
Percentage of participants who meet the NA re-treatment criteria will be reported.
Time frame: Up to 96 weeks